None listed
Conditions
Interventions
Dietary Supplement : Velvet Duchong extraction mixture(KGC01CE) or Placebo
Tablets, 500mg/tablet, 2 Tablets/time, Once a day(morning), Oral administration with water within 30 minutes after meals for
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults (Age=40 years) 2) Those with a Body Mass Index (BMI) of 18.5 kg/? or more and 30 kg/? or less 3) Subjects whose skeletal muscle mass measured by bioelectrical impedance analysis (BIA) is less than 110% of the standard Bioelectrical impedance analysis 4) Subjects who has signed the consent form after being briefed on this study
Exclusion criteria
Exclusion criteria: 1) For the purpose of affects muscle mass and muscle function, people who have taken anabolic steroids (nandrolone, stanozorol, oxandrolone, testosterone, etc.), systemic corticosteroids, androgens (norethindrone acetate, megestrol acetate, high-dose tibolone, etc.), anti-androgens and anti-estrogens (tamoxifen), growth hormone analogs, growth hormone receptor antagonists, protein and amino acid supplements (creatine, leucine, etc.), Velvet Antler, Eucommia ulmoides, Korean herbology, and health functional food. 2) People whose liver function test (AST, ALT, Total bilirubin, Alkaline Phosphatase) value is 2.5 times higher than the normal value 3) People who has a history of renal failure or has a renal function test (creatinine) that is more than 30% higher than the normal value 4) People with a history of hypertension, coronary artery disease, myocardial infarction, angina, heart failure, ischemic heart disease, arrhythmia, cerebral infarction, cerebral hemorrhage, stroke, diabetes, or thyroid disease 5) People with a history of pulmonary disease, systemic autoimmune disease 6) People who has taken diuretics, beta blockers, anticoagulants, or antiplatelet drugs 7) People with injuries or diseases that affect walking, such as rheumatoid arthritis requiring treatment, lower extremity fractures, spinal stenosis with claudication, severe osteoarthritis, or spinal damage 8) Those who have continuously participated in fitness, aerobics, or resistance exercise (strength exercise) within 6 months prior to the study 9) People with Hepatitis B Test Positive 10) Pregnant or lactating women 11) A woman of childbearing age who is not in proper contraception 12) People with a history of alcoholism or substance abuse 13) People with a history of cancer 14) People who has a hypersensitivity to test products 15) People who is at risk of serious drug interaction due to a concomitant drug 16) People who is medically and mentally prohibited from taking investigation drugs 17) People who is legally unable to participate in clinical trials 18) People who participates in another study within six months before the study 19) People who is likely to have an uncooperative attitude in this study or a person who is judged by the researcher to be unable to proceed with the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quadriceps Femoris Muscle Strength | — |
Secondary
| Measure | Time frame |
|---|---|
| Appendicular Skeletal Muscle Index, Appendicular Skeletal Muscle, Total Lean Mass, Total Fat Mass, Hand grip strength, Short Physical Performance Battery, Timed up and go, Insulin-like growth factor-1, Total Testosterone, estrogen, Myostatin;Vital signs, physical examination and measurement, clinical examination, adverse drug reactions, drug use history, Modified Morisky Scale | — |
Countries
Korea, Republic of
Contacts
Public ContactHak Chul Jang
Seoul National University Bundang Hospital
Outcome results
None listed